FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070037
Brand
CoreCare
Company
Corecare Products Inc.
Model
Insulin Syringe, double cap, 0.3ml, 30GX5/16'
Device description
Insulin Syringe, double cap, 0.3ml, 30GX5/16''
Published
2026-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202570000Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.2021-07-02MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091070044PackageGS130In Commercial Distribution
00850091070037PrimaryGS10
10850091070034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070044008500910700448500910700440850091070044
00850091070037008500910700378500910700370850091070037
1085009107003410850091070034

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Regulatory Flags#

DUNS number
134870424
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850091070006CoreCareExam Table Paper 21" 'x 225'2026-09-08
00850091070020CoreCareExam Table Paper 18" x 225'2026-09-08
00850091070051CoreCareInsulin Syringe, double cap, 1ml,30GX5/2026-09-11
00850091070068CoreCareInsulin Syringe, double cap, 0.5ml, 30GX5/16'2026-09-11
00850091070099CoreCareInsulin Syringe, double cap 1ml, 31GX5/16''2026-09-11
00850091070112CoreCareInsulin Syringe, double cap 0.5ml, 31GX5/162026-09-11
00850091070136CoreCareInsulin Syringe, double cap 0.3ml, 31GX5/12026-09-11
00850091070150CoreCareDisposable needle, 18GX1''2026-09-11
00850091070174CoreCareDisposable needle, 25GX1''2026-09-11
00850091070198CoreCareDisposable needle, 22GX1 1/2''(One and half inch2026-09-11
00850091070228CoreCareDisposable needle, 26GX5/8''2026-09-11
00850091070440CoreCareAlcohol Wipe 30x60mm2026-09-08
00850091070457CoreCareAlcohol Wipe 60x60mm2026-09-08
00850091070471CoreCareDisposable needle, 27Gx1 1/2'' (One and half inc2026-09-11
00850091070495CoreCareDisposable needle, 30GX1''2026-09-11
00850091070518CoreCareDisposable needle, 30GX1/2''2026-09-11
00850091070532CoreCare3ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070556CoreCare1ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070570CoreCare5ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070594CoreCare10 ml Luer-Lock Syringes W/O Needle2026-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11
00850091070471CoreCareCorecare Products Inc.FMI2026-09-11
00850091070495CoreCareCorecare Products Inc.FMI2026-09-11